510(k) Report

Devices descending from K003155

2,091 later devices reach Vertebral Body Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K210306GII Spinal Fixation SystemColigne AG20210—
+7K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+7K201671A-Link ZAcuity Surgical Devices, LLC202125—
+7K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+7K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+7K203816DeGen Navigated InstrumentationDegen Medical20211—
+7K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+7K210472SPINEART Navigation Instrument SystemSpineart20215—
+7K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+7K210359Hexanium TLIFSpinevision, S.A.S.20211—
+7K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+7K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+7K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+7K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+7K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+7K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+7K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+7K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+7K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+7K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+7K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+7K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+7K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+7K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+7K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+7K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+7K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K201087CORBEL SpacersGlobus Medical, Inc.202036—
+7K201648Sterispine™ PSSafe Orthopaedics202011
+7K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+7K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+7K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+7K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+7K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+7K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+7K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K200312Tryptik TiSpineart20202—
+7K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+7K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+7K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+7K192897icotec Cervical CageIcotec AG20201—
+7K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+7K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+7K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+7K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+7K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+7K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+7K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+7K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+7K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+7K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+7K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+7K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+7K191134IB3D AlifMedicrea International SA20191—
+7K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+7K1803473d CageFims Co., Ltd.20190—
+7K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+7K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+7K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+7K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+7K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+7K183407Triton CageMedyssey USA, Inc.20190—
+7K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+7K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+7K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+7K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K190488ProLift Expandable SystemLife Spine, Inc.201916—
+7K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+7K183243Velofix TLIF CageU&I Corporation20190—
+7K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+7K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+7K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+7K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+7K190376PASS LP Spinal SystemMedicrea International SA201915
+7K190380nvcNvision Biomedical Technologies, Inc.20193—
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+7K183092Kuros TLIF CageKuros Biosciences B.V20190—